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Life Sciences
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July 10, 2024
Drug Pricing, Overreach Dominate IP Disclaimer Feedback
The U.S. Patent and Trademark Office has received heated feedback regarding its proposal to make follow-on patents easier to invalidate, with drug pricing advocates applauding it, top technology and pharma companies decrying it, and high-profile officials calling the proposal an overstep of the agency's authority.
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July 10, 2024
Medical Imaging Co. Looking To Vacate 'Tainted' Award
A New York federal court has unsealed medical imaging company Molecular Dynamics Ltd.'s still-pending 2022 petition seeking to vacate an allegedly fraudulent arbitral award favoring its former partner in a project to develop cameras in the field of nuclear medicine, revealing more information about the dispute.
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July 10, 2024
GOP Bombards Agencies With Demands After Chevron's End
Republican leaders of major congressional committees Wednesday demanded details from dozens of agencies on policies suddenly shrouded in uncertainty after U.S. Supreme Court conservatives overturned the so-called Chevron doctrine, which for 40 years gave regulators flexibility in rulemaking and advantages in related litigation.
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July 10, 2024
Meijer Says Takeda Can't Force Antitrust Suit Into Arbitration
Meijer argued before a Massachusetts federal court that Takeda waited far too long to try to force the supermarket chain to arbitrate its proposed class action accusing the Japanese pharmaceutical company of conspiring to delay a generic version of its anti-constipation drug Amitiza.
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July 10, 2024
Skin Care Tech Co. Says Suit Shows 'Rough' Year, Not Fraud
Skin care and beauty technology company Cutera Inc. asked a federal judge to toss a shareholder lawsuit that alleged the company exaggerated its financial sustainability and hid compliance issues, saying the company's "rough" year does not establish securities fraud.
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July 10, 2024
Buyers Say Teva Had Multipart Scheme To Delay Inhaler Rivals
Employee benefit funds accusing Teva of orchestrating a decadelong scheme to delay generic competition for its QVAR asthma inhalers told a Massachusetts federal court the drugmaker is trying to end the case by addressing merely one aspect of a multipart scheme.
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July 10, 2024
RJ Reynolds Urges Toss Of Menthol Suit Against FDA
Tobacco giant R.J. Reynolds has come to the support of the U.S. Food and Drug Administration in a friend-of-the-court brief, arguing that the court should toss a federal lawsuit against the agency over its purported delays in implementing a ban on menthol cigarettes.
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July 10, 2024
Ex-FDA Regulator Joins Chicago Boutique Amin Wasserman
A former high-level attorney within the U.S. Food and Drug Administration is joining Chicago-based boutique Amin Wasserman Gurnani LLP, which specializes in representing food and dietary supplement companies.
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July 10, 2024
Longtime Axinn Atty To Chair Polsinelli's Hatch-Waxman Team
A practice leader from Axinn Veltrop & Harkrider LLP, known in part for his high-profile work on behalf of pharmaceutical clients, is joining Polsinelli PC to chair its Hatch-Waxman and biologics practice, the firm announced on Tuesday.
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July 10, 2024
Ex-CEO Convicted In COVID Test Kit Fraud Case
A former healthcare software executive was found guilty of securities fraud Wednesday by a New Jersey federal jury in the retrial of a case that ended in a hung jury in December.
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July 09, 2024
Pharma Co. Fined $16.9M For Fake Scripts, Ex-VP Arrested
A subsidiary of bankrupt DMK Pharmaceuticals Corp. faces a $16.9 million criminal fine after pleading guilty to conspiring in a scheme to ship drugs using false prescriptions, federal prosecutors announced Tuesday, adding that the subsidiary's former vice president of sales was also arrested.
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July 09, 2024
Bard Fights 'Patent Misuse' Ruling In $53M Suit At 9th Circ.
Bard urged the Ninth Circuit on Tuesday to reverse a lower court's finding that its attempt to collect $53 million in licensing payments from a medical-device company was a clear case of "patent misuse," arguing that the parties' licensing agreement allows for Bard to collect payments even after the patents-in-suit expired.
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July 09, 2024
South Africa Drops J&J Probe After TB Drug Price Cuts
South Africa's antitrust office has said it's going to drop its investigation over whether Johnson & Johnson engaged in anticompetitive conduct by filing a patent there for a tuberculosis drug, after the drugmaker agreed to lower the cost of bedaquiline by 40% and allow generic versions of the drug on the market.
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July 09, 2024
Fla. Judge Won't Nix Antitrust Claims Against Alcon
The Florida federal judge presiding over the multidistrict litigation alleging disposable contact lens sellers conspired to fix prices refused Tuesday to let Alcon escape antitrust claims by an online contact lens reseller and sent the suit back to New York.
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July 09, 2024
HEC Can't Get Damages Over Injunction In Novartis Feud
A Delaware federal court on Tuesday shot down HEC Pharm Co.'s bid for damages stemming from a preliminary injunction against it over the launch of a generic version of Novartis Pharmaceuticals' blockbuster multiple sclerosis treatment Gilenya.
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July 09, 2024
BCBS Unit Fails To Stop Religious Vaccine Objector Suits
A Blue Cross Blue Shield of Michigan subsidiary can't escape claims it treated differently employees who sought accommodations from a COVID-19 vaccine mandate, a Michigan federal judge ruled Tuesday, finding it plausible that religious discrimination "was at least a motivating factor" in the way the workers were dealt with.
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July 09, 2024
3rd Circ. Rips 2nd Circ. In Asset Freeze Ruling For SEC
The Third Circuit is standing by a lower court's decision to freeze a private equity executive's assets as he fights insider trading claims brought by the U.S. Securities and Exchange Commission, criticizing its sister circuit's approach to handling such issues in a precedential ruling Tuesday.
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July 09, 2024
NJ Panel Revokes Coverage For Pharma Co. In Fraud Row
A pharmaceutical company isn't covered for underlying accusations that it was a middleman in a self-dealing scheme orchestrated by its now-deceased board chairman, a New Jersey state appeals court ruled Tuesday, reversing a decision that a capacity exclusion in the company's directors and officers policy didn't apply.
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July 09, 2024
Purdue Plans 'High-Speed' Bid For New Ch. 11 Plan
Purdue Pharma told a New York bankruptcy judge Tuesday that it plans a two-month "high-speed, high-stakes" attempt to replace the Chapter 11 plan shot down by the U.S. Supreme Court last month before unleashing litigation on its former owning family.
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July 09, 2024
NJ Jury Begins Deliberating COVID Test Kit Fraud Case
Jurors began deliberating Tuesday in the retrial of a securities fraud case that ended with a dramatic mistrial after a juror announced in open court last December that he disagreed with the guilty verdict that had just been delivered by the jury forewoman.
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July 09, 2024
Terrorism Victims Push To Keep Pharma Suit In DC Circ.
Terrorism victims warned the D.C. Circuit against sending to a lower court a lawsuit seeking to link pharmaceutical companies to the attacks that injured them, saying a remand could delay the case and frustrate their efforts to collect evidence.
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July 09, 2024
FTC Says Drug Middlemen Inflate Costs, Squeeze Pharmacies
The Federal Trade Commission said Tuesday that its study of pharmacy benefit managers has shown that six large companies now control 95% of all prescriptions filled in the U.S., allowing them to profit at the expense of patients and independent pharmacies.
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July 09, 2024
Gov't Missed Merck Vax Potency Problem, 3rd Circ. Told
Two whistleblowers claiming that Merck & Co. had exaggerated the potency of its mumps vaccine told a Third Circuit panel Tuesday that the U.S. Centers for Disease Control and Prevention's continued purchasing of the vaccine was not proof that the agency knew but didn't care about the alleged deception.
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July 08, 2024
Emergent, J&J Reach $50M Deal In COVID Vax Supply Fight
Johnson & Johnson has agreed to pay Emergent BioSolutions $50 million to resolve claims stemming from a now-terminated COVID-19 vaccine manufacturing deal, according to a disclosure filed with the U.S. Securities and Exchange Commission on Monday.
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July 08, 2024
Biotech Slaps Intellia With IP Suit Over $100M Regeneron Deal
Biotechnology company BlueAllele Corp. sued Intellia Therapeutics Inc. in Delaware federal court Monday, claiming the rival has infringed on three of its patents related to gene editing and using its invented technology to reap over $100 million under a deal with another biotech, Regeneron Pharmaceuticals Inc.
Expert Analysis
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Assessing CDC's Revised Guideline On Opioid Prescriptions
Kenneth Weinstein, Nicholas Van Niel and Kate Uthe at Analysis Group look at newly available data to evaluate the impact that the Centers for Disease Control and Prevention's revised opioid monitoring guideline have had on prescription trends in recent years, highlighting both specific and overall decreases.
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Think Like A Lawyer: Forget Everything You Know About IRAC
The mode of legal reasoning most students learn in law school, often called “Issue, Rule, Application, Conclusion,” or IRAC, erroneously frames analysis as a separate, discrete step, resulting in disorganized briefs and untold obfuscation — but the fix is pretty simple, says Luke Andrews at Poole Huffman.
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Valeant Ruling May Pave Way For Patent-Based FCA Suits
The Ninth Circuit’s recent ruling in Silbersher v. Valeant marks a significant development in False Claims Act jurisprudence, opens new avenues for litigation and potentially raises the stakes for patent applicants who intend to do business with the government, say Joshua Robbins and Rick Taché at Buchalter.
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Opinion
Suits Against Insulin Pricing Are Driven By Rebate Addiction
A growing wave of lawsuits filed by states, cities and counties against insulin manufacturers and pharmacy benefit managers improperly allocate the blame for rising insulin costs, when in actuality the plaintiffs are partially responsible, says Dan Leonard at Granite Capitol Consulting.
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Lessons For D&O Policyholders From Pharma Co. Ruling
A California federal court's recent decision in AmTrust v. 180 Life Sciences, requiring insurers to advance defense costs for a potentially covered claim, provides a valuable road map for directors and officers insurance policyholders, rebutting the common presumption that a D&O insurer's duty to advance costs is more limited than under other policies, say attorneys at Pasich.
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How Firms Can Ensure Associate Gender Parity Lasts
Among associates, women now outnumber men for the first time, but progress toward gender equality at the top of the legal profession remains glacially slow, and firms must implement time-tested solutions to ensure associates’ gender parity lasts throughout their careers, say Kelly Culhane and Nicole Joseph at Culhane Meadows.
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7 Common Myths About Lateral Partner Moves
As lateral recruiting remains a key factor for law firm growth, partners considering a lateral move should be aware of a few commonly held myths — some of which contain a kernel of truth, and some of which are flat out wrong, says Dave Maurer at Major Lindsey.
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Series
Cheering In The NFL Makes Me A Better Lawyer
Balancing my time between a BigLaw career and my role as an NFL cheerleader has taught me that pursuing your passions outside of work is not a distraction, but rather an opportunity to harness important skills that can positively affect how you approach work and view success in your career, says Rachel Schuster at Sheppard Mullin.
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Args In APA Case Amplify Justices' Focus On Agency Power
In arguments last week in Corner Post v. Federal Reserve, the U.S. Supreme Court justices paid particular importance to the possible ripple effects of their decision, which will address when a facial challenge to long-standing federal rules under the Administrative Procedure Act first accrues and could thus unleash a flood of new lawsuits, say attorneys at Snell & Wilmer.
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Series
ESG Around The World: Gulf Cooperation Council
The Gulf Cooperation Council is in the early stages of ESG policy implementation, but recent commitments by both states and corporations — including increases in sustainable finance transactions, environmental commitments, female representation on boards and human rights enforcement — show continuing progress toward broader ESG goals, say attorneys at Cleary.
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Opinion
J&J Bankruptcy Could Thwart Accountability For Victims
Johnson & Johnson's latest attempt at a "Texas Two-Step" bankruptcy proceeding exemplifies the way in which corporate defendants can use bankruptcy to evade accountability, limit resources available to victims, and impose flawed, one-size-fits-all resolutions on diverse groups of plaintiffs, says Michelle Simpson Tuegel at Simpson Tuegel Law.
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Inside The PTAB's Seagen Cancer Drug Patent Decision
The Patent Trial and Appeal Board's recent finding that Seagen's claims for antibody-drug conjugate technology were unpatentable — for lack of enablement, lack of written description and anticipation — mark the latest chapter in the complex patent dispute as the case heads for director review, says Ryan Hagglund at Loeb & Loeb.
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6 Pointers For Attys To Build Trust, Credibility On Social Media
In an era of information overload, attorneys can use social media strategically — from making infographics to leveraging targeted advertising — to cut through the noise and establish a reputation among current and potential clients, says Marly Broudie at SocialEyes Communications.
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Opinion
Biden Admin's March-In Plan Would Hurt Medical Innovation
The Biden administration's proposal to reinterpret the Bayh-Dole Act and allow the government to claw back patents when it determines that a commercialized product's price is too high would discourage private investment in important research and development, says Ken Thorpe at the Rollins School of Public Health.
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A Post-Mortem Analysis Of Stroock's Demise
After the dissolution of 147-year-old firm Stroock late last year shook up the legal world, a post-mortem analysis of the data reveals a long list of warning signs preceding the firm’s collapse — and provides some insight into how other firms might avoid the same disastrous fate, says Craig Savitzky at Leopard Solutions.